VAXIOM FAMILY OF RF LESION PROBES & ELEC— 510(k) K802243

Substantially Equivalent

Progress Mankind Technology

FDA 510(k) clearance K802243 for VAXIOM FAMILY OF RF LESION PROBES & ELEC, Substantially Equivalent on 1980-11-12. Applicant: Progress Mankind Technology.

Clearance details

Applicant: Progress Mankind Technology
Product code: Code GXI
Advisory panel: Neurology
Date received: 1980-09-16
Decision date: 1980-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hopkins, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GXI

product code GXI

Death: 3
Injury: 171
Total: 174

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.